Diagnostic and therapeutic methods for cancer

a technology of pdl1 and axis binding antagonist, applied in the direction of instruments, drug compositions, peptide/protein ingredients, etc., can solve the problems of difficult timely detection and treatment, and achieve the effect of responsiveness to treatment and responsiveness to treatmen

Pending Publication Date: 2020-05-21
GENENTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent is about a method for predicting how well a person will respond to treatment with a medication called a PD-L1 binding antagonist. The method involves measuring the level of a certain protein called an immune-score, which is associated with the person's response to treatment. The method can help doctors make better decisions on which treatment to use for each person, improving the effectiveness of treatment and reducing the risk of side effects.

Problems solved by technology

Malignant solid tumors, in particular, metastasize and grow rapidly in an uncontrolled manner, making their timely detection and treatment extremely difficult.

Method used

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  • Diagnostic and therapeutic methods for cancer
  • Diagnostic and therapeutic methods for cancer
  • Diagnostic and therapeutic methods for cancer

Examples

Experimental program
Comparison scheme
Effect test

example 1

on Between Immune-Score Expression Levels of (i) PD-L1, CXCL9, and IFNG or (ii) PD-L1, IFNG, GZMB, and CD8A and Clinical Response of Patients Having Non-Small Cell Lung Cancer (NSCLC) to Treatment with Atezolizumab (MPDL3280A)

[0765]An RNA-based molecular assay was used to evaluate the association between clinical response to treatment with atezolizumab (MPDL3280A), an anti-PD-L1-antibody, and immune-score expression levels of (i) PD-L1, CXCL9, and IFNG or (ii) PD-L1, IFNG, GZMB, and CD8A in patients with non-small cell lung cancer (NSCLC) enrolled in a phase III clinical trial in which atezolizumab was administered as a monotherapy.

Study Design

[0766]The OAK (Clinical Trial ID No.: NCT02008227) patient population evaluated for (i) PD-L1, CXCL9, and IFNG and (ii) PD-L1, IFNG, GZMB, and CD8A expression levels consisted of 753 patients. Patients were eligible for enrollment in the OAK Trial if they had locally advanced or metastatic (e.g., stage IIIB, stage IV, or recurrent) NSCLC; dise...

example 2

on Between Expression Levels of PD-L1, CXCL9, and IFNG and Clinical Response of Patients Having NSCLC to Treatment with Atezolizumab (MPDL3280A)

[0778]An RNA-based molecular assay was used to evaluate the association between clinical response to treatment with atezolizumab (MPDL3280A), an anti-PD-L1 antibody, and expression levels of PD-L1, CXCL9, and IFNG in individuals with NSCLC enrolled in a phase II clinical trial in which atezolizumab was administered as a monotherapy.

Study Design

[0779]The POPLAR (Clinical Trial ID No.: NCT01903993) patient population evaluated for PD-L1, CXCL9, and IFNG expression levels consisted of 215 patients. Patients were eligible for enrollment in the POPLAR study if they had locally advanced or metastatic (e.g., stage IIIB, stage IV, or recurrent) NSCLC; disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable / inoperable, or metastatic NSCLC, or disease recurrence within 6 months of t...

example 3

on Between Expression Level of PD-L1, CXCL9, and IFNG and Clinical Response of Patients Having UBC to Treatment with Atezolizumab (MPDL3280A)

[0785]An RNA-based molecular assay was used to evaluate the association between clinical response to treatment with atezolizumab (MPDL3280A), an anti-PD-L1 antibody, and expression levels of PD-L1, CXCL9, and IFNG in individuals with advanced urothelial bladder cancer (UBC) enrolled in a phase II clinical trial (the IMvigor210 Trial) in which atezolizumab was administered as a monotherapy.

Study Design

[0786]Pre-treatment tumor specimens from patients with advanced UBC who were in Cohort 2 of the Phase II IMvigor210 Trial (Clinical Trial ID No.: NCT02108652) were evaluated for the expression level of PD-L1, CXCL9, and IFNG. Patients were eligible for enrollment in Cohort 2 of the IMvigor210 Trial if they had histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma or the urothelium (e.g., renal pelvis,...

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Abstract

The present invention provides diagnostic methods, therapeutic methods, and compositions for the treatment of cancer. The invention is based, at least in part, on the discovery that an immune-score expression level based on one or more of PD-L1, CXCL9, IFNG, GZMB, CD8A, and PD-1 in a sample obtained from an individual having cancer can be used in methods of predicting the therapeutic efficacy of treatment with a PD-L1 axis binding antagonist (e.g., a PD-L1 binding antagonist (e.g., anti-PD-L1 antibody, e.g., atezolizumab (MPDL3280A)) or a PD-1 binding antagonist (e.g., anti-PD-1 antibody)).

Description

SEQUENCE LISTING[0001]The instant application contains a Sequence Listing which has been submitted electronically in ASCII format and is hereby incorporated by reference in its entirety. Said ASCII copy, created on Sep. 25, 2019 is named 50474-158003_Sequence_Listing_9.25.19_ST25 and is 96,586 bytes in size.FIELD OF THE INVENTION[0002]The present invention is directed to diagnostic and therapeutic methods for the treatment of cancer using PD-L1 axis binding antagonists. Also provided are related assays and kits.BACKGROUND OF THE INVENTION[0003]Cancer remains to be one of the most deadly threats to human health. In the U.S., cancer affects nearly 1.3 million new patients each year and is the second leading cause of death after heart disease, accounting for approximately 1 in 4 deaths. It is also predicted that cancer may surpass cardiovascular diseases as the number one cause of death within 5 years. Solid tumors are responsible for most of those deaths.[0004]Studies in humans with i...

Claims

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Application Information

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IPC IPC(8): C12Q1/6886G01N33/50C07K16/28
CPCG01N2333/96436C07K2317/76G01N2333/70532G01N33/5011A61K38/00G01N2333/57C07K16/2827G01N2800/7028C12Q1/6886G01N2800/52A61K31/555G01N2333/7158C07K16/22A61K31/337G01N2333/70517C12Q2600/106C12Q2600/158A61P35/00
Inventor KOWANETZ, MARCINHUSENI, MAHRUKHZOU, WEI
Owner GENENTECH INC
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